Presentation on theme: "Prop 65 Update October, 2012 T.C.J.J.P. WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or."— Presentation transcript:
Prop 65 Update October, 2012 T.C.J.J.P. WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm
What to do now Know your products Know your typical concentrations Know your exposure Know your NSRLs MADLs Defend your ingredient If you receive a Prop 65 Notice Compounds of concern
Know Your Products Formula ingredients (Sulfur dioxide, Flavors, i.e., Acetaldehyde, Pulegone-pepperment flavor ) Suppliers and material sources (Country of origin) Contaminants (Lead, Pesticides) Reaction by-products (Benzene,) Product packaging (DEHP) In-product reactions (4-MEI, Methanol) Avoidable, removable or manageable?
Know Your Typical Concentrations Intentionally added ingredients, i.e., sulfur dioxide, flavor – Calculate the concentration in your final product Contaminants – Calculate the theoretical maximum using specification limits of ingredients – Test ingredients and final product to determine average levels – Determine if you can use the naturally occurring exemption
Know your exposure Prop 65 limits are based on a per day exposure of the typical consumer Determine Consumer Usage – Consumer Habits and Usage – Published Studies and Models – Primary Intended Exposure(s) – Secondary Routes/Mechanisms for Exposure – Foreseeable Misuse
Know your NSRLs and MADLs Determine your No Significant Risk Level (NSRL) and/or Maximum Allowable Dose Level MADL. – Office of Environmental Health Hazard Assessment (OEHHA) has published some NSRLs and MADLs. – Where not published, calculate using OEHHA Methods – Request a Safe Use Determination?
Defend Your Ingredients Monitor OEHHA for listing-related notices and announcements Track activities of “authoritative bodies” which allow for streamlined chemical listings – National Toxicology Program Challenge proposed listings of chemicals important to your business Once a chemical is listed work with OEHHA to get the highest No Significant Risk Level (NSRL) and/or Maximum Allowable Dose Level (MADL) possible.
If you receive a Prop 65 Notice Obtain Counsel that specializes in Prop 65 Test product to determine if plaintiff’s data is correct If possible, challenge plaintiffs methodology and references – Test data – Exposure model
Compounds of Concern Heavy Metals – Lead 0.5 µg/day (240 ml serving = 2 ppb) – Arsenic 10 µg/day (240 ml serving = 41.6 ppb) Methanol – 23000* µg/day (240 ml serving = 95 ppm) Pesticide – MADL dependant on individual pesticide Sulfur Dioxide – First Priority for MADL Development * Proposed MADL